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Ecological Momentary Assessment Best PracticesExemplarNCT05194228

Exemplar: Determining the Best Practices for EMA Studies

A study testing Ecologial Momentary Assessment settings in people with Ecological Momentary Assessment Best Practices, run by University of Oklahoma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Ecological momentary assessment (EMA) is a measurement methodology that utilizes the repeated collection of real-time data on participants' behavior and experience in their natural environment. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
What is being tested?
Ecologial Momentary Assessment settings
Could I receive a placebo?
No, everyone receives an active treatment
How many people
416 participants
Where
1 siteUnited States
Study dates
30 Nov 2021to 26 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age
  • Demonstrate > 6th grade English literacy level
  • Possess an active Android smartphone that is compatible with the Insight (TM) platform with a data plan and an operating system version 6.0 or higher
  • Agree to install the study smartphone application onto their personal phone
  • Agree to complete EMAs prompted by and completed through the study smartphone application

Who cannot join

  • Under 18 years of age
  • Demonstrates < 6th grade English literacy level
  • Does not possess an active Android smartphone that is compatible with the Insight (TM) platform with a data plan and an operating system version 6.0 or higher
  • Does not agree to install the study smartphone application onto their personal phone
  • Does not agree to complete EMAs prompted by and completed through the study smartphone application

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Ecological momentary assessment (EMA) is a measurement methodology that utilizes the repeated collection of real-time data on participants' behavior and experience in their natural environment. While EMA allows researchers to gain valuable insights into dynamic behavioral processes, the need for frequent self-report can be burdensome and disruptive to participants. Compliance with EMA protocols is important for accurate, unbiased sampling, yet there is no "gold standard" for EMA study design. In the present study, the investigators aim to use a factorial design to identify the optimal components, or combinations of components, for achieving the highest compliance rates for smartphone-based ecological momentary assessments (EMAs). Participants will be randomized into 1 of 32 conditions in a 2x2x2x2x2 design (i.e., number of questions per EMA survey [15 vs. 25] x number of EMAs per day [2 vs. 4] x EMA prompting schedule [random vs. fixed times]) x payment type [per EMA vs. based on percentage of EMAs completed] x order of EMA item question types [i.e., slider type first 2 weeks vs. Likert-type questions first 2 weeks]). All participants will complete EMAs for 4 weeks. The effect of each factor on EMA compliance will be examined, as well as the effects of interactions on EMA compliance. The investigators will also examine within and between-subjects factors that influence response rates, and 2) contextual features such as environment and mood that may be associated with better compliance and participant engagement. The results of this study will have broad applications for developing best practices guidelines for future studies utilizing EMA methodologies.

Read the detailed description

Ecological momentary assessment (EMA) is a measurement methodology that utilizes the repeated collection of real-time data on participants' behavior and experience in their natural environment. EMA has been used in behavioral science for years, including research examining the environmental and psychological antecedents of cigarette smoking, substance use disorders, anxiety, eating, and sleep. EMA sampling strategies are typically time-based or event-based. Time-based sampling is solicited based on a schedule; for example, a daily diary prompted every day at the same time, or at random intervals (e.g., every 3-4 hours) each day. In contrast, event- based sampling is centered around a pre-defined event and is typically initiated by the participant. For example, a participant may be asked to initiate an assessment every time the participant smokes a cigarette.

Several studies have examined the impact of EMA study design features on participant compliance. In a recent meta-analysis of compliance with EMA protocols among substance users, there was no evidence that compliance rates were associated with prompt frequency, length of assessment period, or reimbursement. Another study using a pooled dataset of 10 EMA studies found that compliance declined across days, and varied significantly depending on the time of day. In a meta-analysis of EMA studies in mental health research, a higher number of EMAs per day were associated with lower compliance, however the number of days was not. While these studies provide preliminary guidance regarding EMA study design, their results are unfortunately inconsistent, and the varied reporting across studies with respect to the definition of compliance, study design elements, and study populations make it difficult to clearly derive best practice guidelines for EMA design.

In the present study, the investigators use a factorial design to identify the optimal components, or combinations of components, for achieving the highest compliance rates for smartphone-based ecological momentary assessments (EMAs). In addition, the investigators will explore the association between EMA design features and participant compliance/response rates. A factorial design is ideal for exploring these research questions because it is statistically more efficient, as this type of design needs fewer participants to answer questions about each experimental factor of interest.6 In this study, participants will be randomized into 1 of 32 conditions (i.e., number of questions per EMA survey x number of EMAs per day x EMA prompting schedule x EMA item type x payment type) to explore:

  1. both within and between-subjects factors that influence response rates, and
  2. contextual features such as environment and mood that may be associated with better compliance and participant engagement. The results of this study will have broad applications for developing best practice guidelines for future studies utilizing EMA methodologies.
Being tested
Ecologial Momentary Assessment settings
Keywords
Ecological Momentary Assessment, Health Behavior, Smartphone Application
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ecologial Momentary Assessment settingsBehavioural

    Various settings for ecological momentary assessments

Study groups in NCT05194228
Study groupRoleWhat they receive
Group 1Experimental$1 Payment per EMA 2 EMAs per day 15 questions per EMA Fixed schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 2Experimental$1 Payment per EMA 2 EMAs per day 15 questions per EMA Fixed schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 3Experimental$1 Payment per EMA 2 EMAs per day 15 questions per EMA Random schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 4Experimental$1 Payment per EMA 2 EMAs per day 15 questions per EMA Random schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 5Experimental$1 Payment per EMA 2 EMAs per day 25 questions per EMA Fixed schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 6Experimental$1 Payment per EMA 2 EMAs per day 25 questions per EMA Fixed schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 7Experimental$1 Payment per EMA 2 EMAs per day 25 questions per EMA Random schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 8Experimental$1 Payment per EMA 2 EMAs per day 25 questions per EMA Random schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 9Experimental$1 Payment per EMA 4 EMAs per day 15 questions per EMA Fixed schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 10Experimental$1 Payment per EMA 4 EMAs per day 15 questions per EMA Fixed schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 11Experimental$1 Payment per EMA 4 EMAs per day 15 questions per EMA Random schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 12Experimental$1 Payment per EMA 4 EMAs per day 15 questions per EMA Random schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 13Experimental$1 Payment per EMA 4 EMAs per day 25 questions per EMA Fixed schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 14Experimental$1 Payment per EMA 4 EMAs per day 25 questions per EMA Fixed schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 15Experimental$1 Payment per EMA 4 EMAs per day 25 questions per EMA Random schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 16Experimental$1 Payment per EMA 4 EMAs per day 25 questions per EMA Random schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 17ExperimentalPayment by % EMAs 2 EMAs per day 15 questions per EMA Fixed schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 18ExperimentalPayment by % EMAs 2 EMAs per day 15 questions per EMA Fixed schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 19ExperimentalPayment by % EMAs 2 EMAs per day 15 questions per EMA Random schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 20ExperimentalPayment by % EMAs 2 EMAs per day 15 questions per EMA Random schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 21ExperimentalPayment by % EMAs 2 EMAs per day 25 questions per EMA Fixed schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 22ExperimentalPayment by % EMAs 2 EMAs per day 25 questions per EMA Fixed schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 23ExperimentalPayment by % EMAs 2 EMAs per day 25 questions per EMA Random schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 24ExperimentalPayment by % EMAs 2 EMAs per day 25 questions per EMA Random schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 25ExperimentalPayment by % EMAs 4 EMAs per day 15 questions per EMA Fixed schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 26ExperimentalPayment by % EMAs 4 EMAs per day 15 questions per EMA Fixed schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 27ExperimentalPayment by % EMAs 4 EMAs per day 15 questions per EMA Random schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 28ExperimentalPayment by % EMAs 4 EMAs per day 15 questions per EMA Random schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 29ExperimentalPayment by % EMAs 4 EMAs per day 25 questions per EMA Fixed schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 30ExperimentalPayment by % EMAs 4 EMAs per day 25 questions per EMA Fixed schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 31ExperimentalPayment by % EMAs 4 EMAs per day 25 questions per EMA Random schedule Slider first
Receives: Behavioral: Ecologial Momentary Assessment settings
Group 32ExperimentalPayment by % EMAs 4 EMAs per day 25 questions per EMA Random schedule Likert first
Receives: Behavioral: Ecologial Momentary Assessment settings

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of assigned daily smartphone surveys that are completed.

    Proportion of daily smartphone surveys completed will vary based upon group assignment.

    Measured: through study completion for each participant, 28 days

Secondary outcomes (1)
  1. Number of minutes required to complete the smartphone-based surveys.

    Time to complete smartphone based surveys will vary based upon group assignment.

    Measured: through study completion for each participant, 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2022
  2. Study start30 Nov 2021
  3. Primary completion26 Oct 2022
  4. Study completion26 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Model description
Participants will be randomized into 1 of 32 conditions in a 2x2x2x2x2 design (i.e., number of questions per EMA survey \[15 vs. 25\] x number of EMAs per day \[2 vs. 4\] x EMA prompting schedule \[random vs. fixed times\]) x payment type \[per EMA vs. based on percentage of EMAs completed\] x order of EMA item question types \[i.e., slider type first 2 weeks vs. Likert-type questions first 2 weeks\]).
Masking
None (open label)
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05194228
Sponsor's protocol ID
13684
Acronym
Exemplar
Status last verified
Jan 2023
First submitted
10 Nov 2021
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stone, A. A., & Shiffman, S. (1994). Ecological momentary assessment (EMA) in behavorial medicine. Annals of Behavioral Medicine, 16(3), 199-202. https://doi.org/10.1093/abm/16.3.199

  • Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.

    PubMed 18509902
  • Jones A, Remmerswaal D, Verveer I, Robinson E, Franken IHA, Wen CKF, Field M. Compliance with ecological momentary assessment protocols in substance users: a meta-analysis. Addiction. 2019 Apr;114(4):609-619. doi: 10.1111/add.14503. Epub 2018 Dec 21.

    PubMed 30461120
  • Rintala A, Wampers M, Myin-Germeys I, Viechtbauer W. Response compliance and predictors thereof in studies using the experience sampling method. Psychol Assess. 2019 Feb;31(2):226-235. doi: 10.1037/pas0000662. Epub 2018 Nov 5.

    PubMed 30394762
  • Vachon H, Viechtbauer W, Rintala A, Myin-Germeys I. Compliance and Retention With the Experience Sampling Method Over the Continuum of Severe Mental Disorders: Meta-Analysis and Recommendations. J Med Internet Res. 2019 Dec 6;21(12):e14475. doi: 10.2196/14475.

    PubMed 31808748
  • Fletcher DJ, Lewis SM, Matthews JN. Factorial designs for crossover clinical trials. Stat Med. 1990 Oct;9(10):1121-9. doi: 10.1002/sim.4780091002.

    PubMed 2247713
  • Langford JS, Hebert ET, Jones DR, Tonkin SS, Barker BA, Ulm C, Shi D, Becerra JA, Businelle M. Effects of Ecological Momentary Assessment Prompting Schedule on Affect Measurement Variability and Associations With Next-Day Health Behaviors. Assessment. 2026 May 18:10731911261444953. doi: 10.1177/10731911261444953. Online ahead of print.

    PubMed 42145270
  • Kezbers KM, Robertson MC, Hebert ET, Montgomery A, Businelle MS. Detecting Deception and Ensuring Data Integrity in a Nationwide mHealth Randomized Controlled Trial: Factorial Design Survey Study. J Med Internet Res. 2025 Jan 28;27:e66384. doi: 10.2196/66384.

    PubMed 39874573
  • Businelle MS, Hebert ET, Shi D, Benson L, Kezbers KM, Tonkin S, Piper ME, Qian T. Investigating Best Practices for Ecological Momentary Assessment: Nationwide Factorial Experiment. J Med Internet Res. 2024 Aug 12;26:e50275. doi: 10.2196/50275.

    PubMed 39133915

Questions about this trial

What is this clinical trial studying?

A study testing Ecologial Momentary Assessment settings in people with Ecological Momentary Assessment Best Practices, run by University of Oklahoma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of assigned daily smartphone surveys that are completed. (time frame: through study completion for each participant, 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05194228, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.

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